FDA Adverse Event
Other
Summary report: N
K-Y JELLY PERSONAL LUBRICANT
MDR report key: 2560038
·
Received April 29, 2010
Report
- Report Number
- 2214133-2010-00006
- Event Type
- Other
- Date Received
- April 29, 2010
- Report Date
- March 18, 2010
- Manufacturer
- J&J HEALTHCARE PRODUCTS DIV MCNEIL-PPC, INC.
- Product Code
- KMJ
- PMA / PMN Number
- K810310
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF THIS SUBMISSION IS (B)(4) 2010. THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
Description of Event or Problem · 1
ON (B)(6) 2010, THE CONSUMER INDICATED THAT HE RECENTLY FOUND A BOTTLE OF KY JELLY IN HIS MEDICINE CABINET AND NOT KNOWING IT WAS 4 YEARS OLD, USED IT. THE CONSUMER CALLED AGAIN ON (B)(6) 2010 AND CLAIMED THE PRODUCT GAVE HIM (B)(6). HE CHECKED THE (B)(6) OF HIS PENIS AND IT HAS LITTLE PIMPLES ON IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | K-Y JELLY PERSONAL LUBRICANT | PERSONAL LUBRICANT | KMJ | J&J HEALTHCARE PRODUCTS DIV MCNEIL-PPC, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |